DRUG

EVALUATION
DRUG EVALUATION
EVALUATION:
Means confirmation of drug identity and
determination of its quality and purity.
The various methods of evaluation are as
follows:
1. Organoleptic evaluation
2. Microscopic evaluation
3. Physical evaluation
4. Chemical evaluation
5. Biological evaluation
1) ORGANOLEPTIC EVALUATION
 It refers to evaluation of drugs by color, odour, taste, size,
shape and special features, like touch, texture, sounds etc.
 However, it should be noted that colour, shape and size of
crude drugs as described in official books should only be
considered as guidelines and may vary depending upon
several factors.
 For example colour of crude drug may fade if it gets
exposed to sunlight for very long duration or if, the drug
is not stored properly.
 Depending upon the conditions under which the drug is
growing or cultivated, i.e. availability of proper
irrigation, fertilizer or even, high temperature, may
influence the size of drug.
2. MICROSCOPIC EVALUATION
 This method allows more detailed examination of a drug
and it can be used to identify organised drugs by their
know histological characters.
 The characteristics of cell walls, cell contents, trichomes,
fibres, vessels can be studied in details.
 The following few constants illustrate the importance of
microscopic measurements, for leaf drugs.
I- Stomatal number
S- Number of stoma per unit area
E- Epidermal cells in the same area.
A. Stomatal number: It is the average number of stomata
present per square mm of the epidermis.
Example: Datura stramonium- 87 stomatal number
Datura innoxia- 141 stomatal number
B. Stomatal index:
It is the percentage which the number of stomata to the
number of epidermal cells, each stoma being counted as one
cell.
It is calculated as follows.
Example:
Atropa belladonna- 20.2 to 23
Atropa accuminata- 16.2 to 18.3
Indian senna- 17 to 20
Alexandrian senna- 10 to 12.6
C. Vein islet number
It is the number of vein islet per square mm leaf surface
and it is constant for given species of plant.
Example
Digitalis purpurea- 2 to 5.5
Digitalis thapsis- 8.5 to 16
Cassia angustifolia- 19 to 23
D. Palisade ratio
It is an average number of palisade cell beneath each
epidermal cell using four continuous epidermal cell.
Example
Atropa belladonna- 6 to 10
Digitalis purpurea- 3.7 to 4.2
E. Quantitative microscopic method (Lycopodium spore
method):
• These analytical method are used for powdered drugs.
• e.g. ginger, clove, cardamom.
• Lycopodium spores are characteristics in shape, size and
appearance exceptionally uniform in size (25um).
• The percentage purity of an authentic powder ginger is
calculated using the equation as given below:
Percentage purity: N×W×9400× 100
S×M×P
N: Number of characteristic structure in 25 fields
W: Weight in mg of Lycopodium taken
S: Number of Lycopodium spores in the fields
M: Weight in mg of sample
P: 2,86000 in case of ginger, starch grain powder.
3. PHYSICAL EVALUATION
The physical constants of drugs are determined by this
method. Following are the physical constant.
A. Moisture contents: The moisture content is determined
by heating a drug at 105 degree centigrade in an oven to
constant weight.
Example:
Aloe- 10% Digitalis- 5%
B. Refractive Index: Depending upon purity, RI is a
constant for a liquid and can be considered as one of the
criteria for its standardization.
Example:
Arachis oil: 1.4678 to 1.4698
Caraway oil: 1.4838 to 1.4858
Castor oil: 1.4758 to 1.4798
C. Melting point: In case of pure drug m.p. are very
sharp and constant. The purity of crude drugs can be
determined by their m.p. in the range as shown below.
Example:
Beeswax: 60-65 Cocca butter: 30-33
D. Optical Rotation: Certain substances are found to
have property of rotating the plane of polarized light in
pure state or in the solution.
Example:
Castor oil: not less than +3.5
Clove oil: 0 to -1.5
E. Ash content: The residue remaining after
incineration is the ash content of the drug. Which
simply represents the inorganic salts naturally
occurring in drug or deliberately added to it as a form
of adulteration.
Example:
Aloe: 5.00 %w/w
Ashoka: 11 %w/w
Clove: 7 %w/w
a. Acid insoluble ash: It is the part of total ash
insoluble in dil.HCL acid, is also recommended for
certain drugs. Adhering dirt & sand may be
determined by acid insoluble ash content.
Example
Agar: not more than 1 % w/w
Belladonna: not more than 3 % w/w
Cannabis: not more than 1 % w/w
b. Extractives: Depending upon the chemical nature and properties of
contents of the drugs, various solvents are used for determination of
extractives. The various methods used to find out the extractive values
are:
i. Water soluble extractives: This method is applied to drugs which
contain water soluble active constituents of crude drugs such as tannins,
sugars, mucilage etc.
Examples
Aloe: not less than 25 %w/w
Linseed: not less than 15 %w/w
Senna leaves: not less than 30 %w/w
Ginger: not less than 10 %w/w
ii. Alcohol soluble extractives: Alcohol is an ideal solvent for
extraction of various chemicals like tannins, resin etc. Therefore this
method is frequently used to determine the approximate content of resin.
Examples:
Aloe: not more than 10 %w/w
Benzoin: not more than 90 %w/w
Rhubarb: not less than 30%w/w
iii. Ether soluble extractives:
• Two types of ether soluble extractive values determined
for evaluation of crude drugs are volatile and non volatile
ether soluble fractions.
• The volatile ether soluble extractive represents volatile
oil contents of the drugs, while non volatile ether soluble
extractives represents resin, fixed oil or coloring matter
presents in drugs.
Examples:
Capsicum: not more than 12 %w/w of non volatile content
Linseed: not more than 25 %w/w of non volatile content
Caraway: not more than 2.5 %w/w of volatile content
Clove: not more than 15 %w/w of volatile content
Dill: not more than 2.4 %w/w of volatile content
5.CHEMICAL EVALUATION
• It consist of chemical test and chemical assay for isolation,
purification and identification of active chemical constituents.
• Quantitative chemical test such as acid value, Saponification
value, total alkaloids, glycosides content etc. are useful in
evaluation of resin (acid value), balsam (acid, Saponification or
ester values), volatile oil (acetyl and ester value), gum
(methoxy determination).
• Phytochemical screening is carried out with the help of different
chemical test.
• The alkaloid containing drug such as Rauwolfia, belladonna,
ergot, ipecac and Glycoside containing drugs like senna,
digitalis can be identified with the help of specific chemical
test.
Examples of chemical test
-Copper acetate test for resin, balsams, waxes to determine
colophony as an adulterant.
-Vitali Morin test for propane, alkaloids, Datura,
belladonna.
-Sulphuric acid test detecting strychnine in nux-vomica.
-Brontragers test for detecting anthraquinone glycoside
present in senna, aloe.
Chemical assay: Titrimetric and gravimetric methods are the
techniques of chemical assays.
The alkaloidal drugs analyzed for their total alkaloidal
content are opium (morphine), belladonna (atropine),
ipecacuanha (emetine), nux-vomica (strychnine), cinchona
(quinine), Rauwolfia (Reserpine) and ergot (ergometrine).
Chemical assays are carried out for cineole in eucalyptus oil,
aldehydes in lemon oil, carvone in caraway oil & dill oil.
5. BIOLOGICAL EVALUATION
It is also called as bioassay. It is the method in which drug potency
is determined by its effects on living microorganism, living tissue
or on entire animal.
e.g. Drugs like digitalis for cardiac activity, vitamins, hormones,
antibiotics are tested for their antibacterial activity.
In toxic and symptomatic technique the animals are used whereas
in tissue method the effect of a drug is observed on isolated organ
or tissue.
In other words, bioassay is measure of sample being tested capable
of producing the biological effects as that of the standard
preparation.
Thank you